JMIR Publications

ABSTRACT

Background:

Patients with post-COVID-19 Condition (PCC) experience a wide range of complaints (physical, cognitive, and mental), sometimes with high levels of disability in daily activities. Evidence of effective interdisciplinary rehabilitation treatment is lacking. A person-centered biopsychosocial, interdisciplinary rehabilitation program, adapted to expert opinions and the patient’s needs, was therefore developed.

Objective:

The aim of the study is to present a study protocol for a clinical trial for evaluating the effect of a new person-centered interdisciplinary rehabilitation treatment of post-COVID condition (PCC). Which is aimed at improving participation in society and health related quality of life (HRQoL), in patients with PCC who perceive a high level of disability in daily activities and/or participation.

Methods:

20 Dutch adults, 18 years or older, with high levels of disability in daily activities and/or participation in society will be included in this Replicated and Randomized-Single Case Experimental Design (R-SCED) study, from October 2023 onwards. The R-SCED consists of three phases. The baseline phase (A) is the observational period, in which no specific treatment will be given. In the intervention phase (B), patients will receive the new outpatient treatment three times a week for 12 weeks, followed by a 12-week follow-up phase. The treatment will be personalized according to the patient’s physical, mental, and cognitive symptoms and goals. The treatment team can consist of a rehabilitation physician, physiotherapist, occupational therapist, speech therapist, and psychologist. Primary outcomes of the study are daily diaries, which consist of 8 questions selected from validated questionnaires (USER-P, EQ5D-5L, and the Hospital Anxiety and Depression Scale (HADS)). The other primary outcome measurements are participation in society (USER-P) and HRQoL (EQ5D-5L). The secondary outcomes are physical tests and validated questionnaires aimed at physical, mental, and cognitive complaints.

Results:

Data collection for this study started in October 2023 and is planned to be completed in July 2024. The results will be published in peer-reviewed journals and presented at (inter)national conferences.

Conclusions:

To our knowledge, this is the first study investigating the effect of an interdisciplinary rehabilitation treatment with a person-centered biopsychosocial approach in patients with PCC. Our findings will help to improve the treatment and support of PCC patients. Clinical Trial: German Clinical Trials Register, DRKS00032636.